Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

Phase 2

Active, not recruiting

• Conditions: Early Alzheimer's Disease
• Interventions: Drug: ALZ-801

• Registration Number: NCT04693520
• Lead Sponsor: Alzheon Inc.

Brief Summary

The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Primary Completion: 2023-08-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active treatment	ALZ-801	ALZ-801 265 mg tablets once daily for two weeks and twice daily thereafter

Primary Outcome Measures

Name	Time	Method
Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume	Week 104	Change from baseline in hippocampal volume measured in mm3
Plasma Biomarker of Core AD Pathology	Week 104	Percent change from baseline in p-tau181
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)	Week 108	Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.

Secondary Outcome Measures

Name	Time	Method
Additional CSF Biomarkers of AD Pathology and Neurodegeneration	Weeks 104 and 156	Percent changes from baseline for: p-tau217,Aβ-40, Aβ-42, NfL, t-tau, sTREM2, YKL-40 and neurogranin
Plasma Biomarker of Core AD Pathology	Week 156	Percent change from baseline in p-tau181
Plasma Biomarkers of AD and Neurodegeneration	Weeks 104 and 156	Percent changes from baseline in: Aβ-40, Aβ-42,p-tau217 and plasma glial fibrillary acidic protein (GFAP),NfL
vMRI Biomarker - Ventricular volume and Cortical Thickness	Weeks 104 and 156	Change from baseline in cortical thickness measured in mm3
Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume	Week 156	Change from baseline in hippocampal volume measured in mm3
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)	Week 160	Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.

Trial Locations

Locations (4)

Brain Research Center; 🇳🇱 Zwolle, Netherlands

Vestra Clinics; 🇨🇿 Rychnov Nad Kněžnou, Czechia

St. Anne's University Hospital; 🇨🇿 Brno, Czechia

Motol University Hospital; 🇨🇿 Prague, Czechia